Background
Recurrence of Clostridioides difficile infection (rCDI) is common, prolonging disease morbidity and leading to poor quality of life. We evaluated disease-specific health-related quality of life (HRQL) in patients with rCDI treated with fecal microbiota, live-jslm (REBYOTA [RBL]; Rebiotix) versus placebo.
Methods
This was a secondary analysis of a randomized, double-blind, placebo-controlled phase 3 study (PUNCH CD3). The disease-specific Clostridioides difficile Quality of Life Survey (Cdiff32) was administered at baseline and at weeks 1, 4, and 8. Changes in Cdiff32 total and domain (physical, mental, social) scores from baseline to week 8 were compared between RBL and placebo and for responders and nonresponders.
Results
Findings were analyzed in a total of 185 patients (RBL, n = 128 [69.2%]; placebo, n = 57 [30.8%]) with available Cdiff32 data. Patients from both arms showed significant improvements in Cdiff32 scores relative to baseline across all outcomes and at all time points (all P < .001); RBL-treated patients showed significantly greater improvements in mental domain than those receiving placebo. In adjusted analyses, RBL-treated patients showed greater improvements than placebo in total score and physical and mental domains (all P < .05). Similar improvement in mental domain was observed among responders, while nonresponders showed numerical improvements with RBL but not placebo.
Conclusions
In a phase 3 double-blinded clinical trial, RBL-treated patients reported more substantial and sustained disease-specific HRQL improvements than placebo-treated patients.
Associated People
Mirko Fillbrunn
Dr. Fillbrunn specializes in health economics and outcomes research (HEOR), biostatistics, and epidemiology. His expertise includes strategically developing and guiding the implementation of analytics throughout the entire product life cycle, including analyses of clinical trials and real-world health care data such as insurance claims, electronic health records, medical charts, and surveys. Dr. Fillbrunn’s contributions have informed clinical regulators and health care payers in both the US and global markets. His research has been published in several peer-reviewed journals and presented at clinical and health economic conferences. Prior to joining Analysis Group, Dr. Fillbrunn was a postdoctoral fellow at Harvard Medical School and Massachusetts General Hospital.